The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1832-2017·Announced 2017-05-03

HeartWare HVAD Pump Driveline Splice Kit Recall for Improved Repair

Medtronic is notifying clinicians that an improved splice kit is available to replace the HeartWare HVAD Pump Driveline Splice Kit due to a safety issue.

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: "In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new…"

Plain-English summary

Medtronic, which now owns HeartWare, is issuing a follow-up communication to identified clinicians regarding the HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit. This recall follows a safety issue notification issued by HeartWare in April 2015. The splice kit is intended to repair the driveline cable once an electrical break has been identified, specifically for the portion of the driveline outside the patient boundary.

The recall involves 9 units of the splice kit, identified by product codes ASY00116 and ASY00281. The distribution pattern includes worldwide distribution, with specific US nationwide distribution in Florida, Missouri, Tennessee, Kentucky, and New York, as well as distribution in Germany. The recall applies to all patients who had a driveline splice repair performed prior to April 2015.

Medtronic intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available. Clinicians should contact Medtronic or HeartWare for further instructions on how to obtain the improved kit and manage the safety issue.

The recalled product

Product
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit…
Manufacturer
Heartware
Category
Medical Device — Cardiovascular
Hazard
Affected units
9

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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