Agency classClass IOur severity:Severe FDA (Devices)·Z-1276-2015·Announced 2015-03-25

Medtronic FlexCath Select Steerable Sheath Recalled for Valve Debris

Medtronic is recalling 151 FlexCath Select Steerable Sheaths because clinicians observed debris originating from the hemostasis valve outside of patients' bodies.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies."

Plain-English summary

Medtronic Inc. Cardiac Rhythm Disease Management is recalling the 10 Fr FlexCath Select Steerable Sheath (Catalog Number 990065). This single-use, non-implantable device is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The recall involves 151 units, with 4 distributed in the United States and 147 distributed outside the United States.

The recall was initiated after clinicians observed debris appearing to originate from the hemostasis valve on the proximal end of the sheath outside of patients' bodies. The affected lot numbers are 54790, 54860, 54876, 54877, 54878, 72417, and 72419.

Distribution occurred in the United States (North Carolina and Iowa) and in Austria, Belgium, Denmark, France, Germany, the Netherlands, Poland, Spain, and the United Kingdom. Healthcare providers should stop using the affected devices and contact Medtronic for instructions on return or replacement.

The recalled product

Product: Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
Manufacturer: Medtronic Inc. Cardiac Rhythm Disease Management
Category: Medical Device — Cardiac Catheter
Hazard: debris
foreign-object

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

Lot Number: 54790
54860
54876
54877
54878
72417
72419.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management

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Same hazard · debris