Health product recall

In.Pact Admiral Paclitaxelcoated Pta Balloon Catheter

Brand(s)
Last updated

Summary

Product
In.Pact Admiral Paclitaxelcoated Pta Balloon Catheter
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

In.Pact Admiral Paclitaxelcoated Pta Balloon Catheter

Not applicable.

ADM07006013P, ADM05004013P, ADM06008013P, ADM04015013P, ADM06004013P, ADM05008013P, ADM06015013P

Issue

During a routine inspection Medtronic noted there was damage to the sterile pouch that contains the In.Pact Admiral Catheters. Upon investigation, there had been a change implemented to one manufacturing line which may cause pouch damage. All batches manufactured on this line after that change are being retrieved. Damage to the pouch can cause a loss of sterility and may result in potential clinical harm of systemic reaction including infection. The affected units are limited to specific lot numbers of In.Pact Admiral Catheters. No other Medtronic products are affected by this issue. Through 11-March-2022, Medtronic has received no (0) complaints involving this issue. There are no actions required for patients where the affected In.Pact Admiral Catheters were used during a procedure. These patients should continue to be monitored in accordance with the medical facility's standard care protocols.

Recall start date: Mar 25, 2022

Additional information

Details
Original published date: 2022-04-07
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Medtronic Inc.

710 Medtronic Parkway N.E., Minneapolis, Minnesota

United States, 55432

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64045