FDA issued 176 Class I medical device recalls in 2013. That’s up from 150 in 2012 but far lower than the 426 issued back in 2010, according to DeviceMatters, a provider of regulatory and safety insights and analytics for the industry.
MD+DI analyzed FDA’s list of Class I recalls from 2013 to determine which companies had the most Class I recall events last year. Because recalls typically come in clusters, with many recalls that affect similar products issued on the same day, we combined recalls issued on the same date for similar or associated products to come up with the number of recall events for each company.
This list should be viewed with caution, however. Companies that make more life-supporting or –sustaining medical devices are more likely to issue a higher number of Class I recalls, of course, than companies that only make a few such devices. This list also doesn't account for the seriousness of recalls. Cook Medical, for example, was not among our list of companies with the most Class I recall events last year, but, according to FDA's recall database, it issued Class I recalls after receiving "a small number of complaints related to the delivery system for the Zilver PTX Drug Eluting Peripheral Stent involving fractures of the delivery system inner catheter after deployment and separation of the inner catheter tip section," and "two adverse events, including one death, occurred in cases where a tip separation" occurred.
With those caveats in mind, here are the companies that had the most Class I recall events in 2013:
Medtronic: 6 Class I Recall Events
With six Class I recall events, Medtronic had the most of any medical device company in 2013. Class I recalls were issued for problems with the following products:
- Medtronic MiniMed Paradigm insulin infusion sets
- Medtronic intrathecal catheters, pump segment revision kits, and sutureless pumps connector revision kits
- SynchroMed EL and II implantable infusion pumps
- Activa dystonia therapy kits and deep brain stimulation lead kits
- Attain Hybrid, Cougar Nitinol Workhorse, Cougar Steerable, ProVia crossing, Thunder Steerable, Zinger Stainless Steel Workhorse, and Zinger Steerable guidewires
- NIM TriVantage EMG endotracheal tubes
Johnson & Johnson companies and GE Healthcare: 5 Class I Recall Events
With five each, J&J companies and GE Healthcare were tied for the second most Class I recall events in 2013.
J&J’s Class I recalls spanned subsidiaries Animas Corp., Cordis Corp., DePuy Orthopaedics, and Lifescan, and covered the following products:
- Animas inuslin infusion pumps (Animas)
- OptEase vena cava filters (Cordis)
- LPS diaphyseal sleeves (DePuy Orthopaedics)
- Dovetail intercalary components (DePuy Orthopaedics)
- OneTouch Verio IQ blood glucose monitoring system (Lifescan)
GE Healthcare’s Class I recalls affected the following products:
- Giraffe OmniBed and incubator
- Multi Absorber Original disposable for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block and the GE Healthcare Compact Block II (later Compact Block)
- Giraffe and Panda bag and mask and and warmer T-piece resuscitation systems
- Various nuclear imaging systems
- Aisys, Amingo, Avance, Avance CS2, Aespire View, and Engstrom devices for volume or pressure control ventilation
CareFusion and Hospira: 4 Class I Recall Events
With four each, CareFusion and Hospira tied for the third most Class I recall events in 2013.
Carefusion issued one recall for its Avea Ventilator and three for its Alaris PC unit.
Hospira’s GemStar infusion system was associated with three separate recall events, and the company also recalled a number of its blood sets.