The world’s biggest medical device recalls

Tiash Saha 30 April 2019 (Last Updated January 30th, 2020 11:06)

Nine out of ten biggest recalls fall into the US Food and Drug Administration’s (FDA) Class I device recall category, which represents serious health hazards and even death due to device defects. One of the world’s biggest medical devices company, Abbott Laboratories appears twice in the list. Medicaldevice-network lists the ten biggest medical device recalls worldwide, based on the number of units recalled.

The world’s biggest medical device recalls
Vial2Bag’s 13mm device had serious health effect on pregnant women while administering oxytocin during delivery.

The biggest medical device recalls worldwide: Ranking the top ten

10. Medtronic’s dual chamber pacemakers- 156,957 units

9. Abbott’s defibrillators – 175,624 units

8. ICU Medical’s vial spikes – 221,275 units

7. Dexcom’s glucose monitoring system – 263,520 units

6. CareFusion’s Alaris Pump Module – 382,635 units

5. Nurse Assist’s Saline Flush IV syringes – 386,175 units

4. Abbott’s cardiac pacemakers – 465,000 units

3. Cook Medical’s catheters – 4.14 million units

2. Magellan Diagnostics’ blood lead testing systems – 7.05 million units

1. West Pharmaceutical’s fluid transfer systems – 38.8 million units

10. Medtronic’s dual chamber pacemakers- 156,957 units

Medtronic recalled its Adapta™, Versa™ and Sensia™ brands of dual chamber pacemakers in January 2019. Image courtesy of Medtronic.

Medtronic issued a worldwide voluntarily recall of the Adapta, Versa and Sensia brands of dual chamber pacemakers in January 2019 due to the susceptibility to circuit failure.

The affected devices showed circuit error when programmed to a dual chamber mode for sensing atrial activity. The modes without atrial-sensing activity are not susceptible to the error.

The defect affected the normal pacing activity of the device. Two patients out of four reported cases noted pause in pacing therapy although no deaths were reported due to the issue.

A change in design of the integrated circuit of pacemakers distributed between March 2017 and January 2019 was considered as the potential cause of the error. The company is developing a software update to rectify the issue; customers will be notified upon availability.

9. Abbott’s defibrillators – 175,624 units

Abbott recalled Fortify, Unify, and Assura models of ICDs and CRT-Ds in August 2017. Image courtesy of US Food and Drug Administration.

Abbott Laboratories recalled its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) in the US in August 2017 due to premature battery depletion complaints.

Lithium deposition within the battery led to short circuits in the device thereby causing battery depletion. Without any back-up, the battery depletion issue had the potential to cause an abrupt stoppage of the life-saving pacemakers in patients, leading to death.

The recalled devices include the Fortify, Unify, and Assura models of ICDs and CRT-Ds.  Abbott had recalled 251,346 units nationwide in October 2016, but later reduced it to 175,624 units and added information regarding Battery Performance Alert (BPA).

BPA is a battery performance management tool to notify physicians regarding improper functioning, which could lead to power failure.

8. ICU Medical’s vial spikes – 221,275 units

ICU Medical recalled 221,275 units of ChemoLock™ and ChemoClave® vial spikes in February 2019. PRNewsFoto/ICU MEDICAL_ INC.

ICU Medical voluntarily recalled 160,775 units of ChemoLock and 60,500 units of 20mm ChemoClave® vial spikes worldwide in February 2019 due to the potential presence of plastic burr particulate.

The particulate was considered to have originated from the protective cap used during device assembly. It had the potential to enter a patient’s body during intravenous infusion, causing embolism and death.

ChemoLock was the first needle-free closed system transfer device that received FDA clearance in September 2013. The defective product lot was distributed in the US between August 2018 and February 2019.

7. Dexcom’s glucose monitoring system – 263,520 units

Dexcom’s G4 Platinum and G5 mobile continuous glucose monitoring systems were recalled due to a faulty auditory alarm in February 2016. PRNewsFoto/Julphar

The FDA recalled all the models of Dexcom’s G4 Platinum and G5 mobile continuous glucose monitoring (CGM) systems due to a faulty auditory alarm in February 2016.

The CGMs include a sensor and a receiver. The sensor is placed subcutaneously to measure blood glucose readings in patients, which are sent to the receiver. The alarm remains inactive in the defective CGM during high or low blood glucose levels in patients, which may cause serious adverse events or even death.

The company pulled out all the G4 Platinum and G5 monitoring devices from the market, which were distributed between October 2012 and March 2016.

6. CareFusion’s Alaris Pump Module- 382,635 units

CareFusion recalled 382,635 units of Alaris Pump Module in December 2016. Image courtesy of Attila Malarik.

Becton Dickinson’s subsidiary CareFusion recalled 8100 model Alaris Pump Modules along with air-in-line (AIL) sensor kits in December 2016 due to an error in alarm, which may interrupt the on-going therapy.

Alaris is a large volume infusion pump for delivering fluids such as blood and medicines to the patient’s body in a controlled manner. The defective AIL sensor generates a false alarm causing the pump to stop infusion in the patient leading to life-threatening, adverse events.

A class II recall was also made in the same year for the pump module, which affected 35,940 units distributed in the US and Canada.

5. Nurse Assist’s Saline Flush IV syringes – 386,175 units

Nurse Assist’s Saline Flush IV syringes were recalled due to possible B. cepacia contamination in October 2016. Image courtesy of the U.S. Food and Drug Administration.

Nurse Assist voluntarily recalled all lots of Saline Flush IV syringes distributed in the US from February 2016 to September 2016 due to possible Burkholderia cepacia (B. cepacia) contamination, in October 2016.

The syringes are pre-filled with saline and used to flush the medical devices that use either needle or catheter for direct delivery of medicines into the bloodstream of the patients. Contamination with B. cepacia bacteria had the potential to cause bloodstream infections, especially in people with weak immune systems.

The Centers for Disease Control and Prevention (CDC) identified the contaminated syringes as a source of B. cepacia infections outbreak in various regions of the US in 2016 that affected 163 people from 59 facilities and caused seven deaths.

4. Abbott’s cardiac pacemakers – 465,000 units

Abbott’s cardiac pacemakers recall falls into the FDA’s Class II device recall category. Photo: Business Wire.

The FDA issued a voluntary recall for six brands of implantable cardiac pacemakers of Abbott due to cyber security concerns in August 2017. The faulty pacemakers implanted in the patients could potentially be hacked to alter the patients’ heart rate.

The company’s pacemakers and cardiac resynchronisation therapy pacemaker (CRT-P) devices under the brand names Accent, Anthem, Accent MRI, Accent ST, Assurity, and Allure were affected by the recall.

The class II recall, however, did not intend to remove the implanted pacemakers from the patients as the invasive medical procedure could endanger the lives of 465,000 patients. The implanted devices were updated by medical staff. The company eventually developed more secure software, which includes data encryption, operating system patches, network connectivity disabling ability features, in addition to firmware updates.

3. Cook Medical’s catheters – 4.14 million units

A total of 408,011 catheters with Beacon® Tip technology were affected by the recall in the US alone. Photo: Business Wire.

Cook Medical voluntarily recalled more than 4.14 million catheters with Beacon® Tip technology due to reports of tip fracture and separation in April 2016. A total of 408,011 catheters were affected by the recall in the US alone.

The company received complaints regarding polymer degradation of the catheter tip causing its fracture and separation. The defect could have stopped the device from working, while the tip could enter the patient’s bloodstream and cause serious adverse health consequences.

The recall was initiated for a few lot numbers in 2015, but extended globally due to the increased number of complaints in April 2016.

2. Magellan Diagnostics’ blood lead testing systems – 7.05 million units

LeadCare blood lead testing systems were recalled globally due to false test results in May 2017. Image courtesy of Philip Jeffrey.

Magellan Diagnostics’ LeadCare blood lead testing systems were recalled worldwide in May 2017 for providing inaccurate test results.

The LeadCare and the LeadCare II testing systems detect the amount of lead in the blood sample taken from capillary or vein of patients. LeadCare II is a Clinical Laboratory Improvement Amendments (CLIA)-waived lead diagnostics system, which utilises an electrochemical test method with disposable sensors. It detects the level of lead in the blood in three minutes by a simple finger stick test.

The recalled systems may have determined the blood lead levels inaccurately and provided false results, which could have led to providing improper patient treatment with lead exposure or poisoning.

1. West Pharmaceutical’s fluid transfer systems – 38.8 million units

Vial2Bag’s 13mm device had serious health effect on pregnant women while administering oxytocin during delivery.

West Pharmaceutical Services recalled more than 38.8 million units of Vial2Bag fluid transfer systems worldwide in January 2019 due to functioning issues.

The system connects different types of medication vials to an intravenous (IV) therapy bag for mixing before administering to the patients. The potential risk of inadequate transfer of concentrated medicine from vial to bag may have led to either an overdose or underdose of medication to patients, causing life-threatening events.

The FDA received 16 complaints against the Vial2Bag’s 13mm device for having serious adverse health consequences in pregnant women while administering oxytocin during delivery.