Medtronic IN.PACT Admiral balloon catheters recalled for damaged packaging
Medtronic is recalling IN.PACT Admiral paclitaxel-coated balloon catheters due to damaged packaging that may result in loss of sterility, affecting approximately 6,035 units worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving damaged packaging that may compromise sterility. No illnesses or injuries have been reported. While loss of sterility on a medical device poses a theoretical risk of infection, the hazard has not yet resulted in reported harm, meeting the criteria for High severity as a risk-of-harm product without reported injuries.
Plain-English summary
Medtronic Vascular, Inc. is recalling multiple models of the IN.PACT Admiral Paclitaxel-coated Peripheral Transluminal Angioplasty (PTA) Balloon Catheter. The affected units are sterile, single-use medical devices identified by specific model numbers and lot numbers listed in the recall notice.
The recall was initiated because the packaging for these balloon catheters may be damaged, which could result in loss of sterility. A non-sterile medical device intended for internal use poses a potential risk of infection or other complications.
The affected devices were distributed worldwide, including throughout the United States and to multiple countries in North America, South America, Europe, Asia, Africa, and Oceania. Approximately 6,035 units are involved in this recall.
Healthcare providers and patients who have received these devices should consult with their physician immediately. Medtronic Vascular, Inc. is working with healthcare facilities to identify and manage recalled products.
The recalled product
- Product
- Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05
- Manufacturer
- Medtronic Vascular, Inc.
- Hazard
- damaged-packaging
- loss-of-sterility
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 (20)
- Model Number Lot Number GTIN ADM04004013P 0010935559 00643169383500
- ADM04008013P 0010935575 00643169383524
- ADM04008013P 0010935574 00643169383524
- ADM04008013P 0010861910 00643169383524
- ADM04012013P 0010968204 00643169383531
- ADM04015013P 0010891542 00643169576315
- ADM04015013P 0010975488 00643169576315
- ADM04025013P 0010904889 00643169975064
- ADM05004013P 0010861907 00643169383609
- ADM05004013P 0010985886 00643169383609
- ADM05006013P 0010863869 00643169383616
- ADM05006013P 0010954041 00643169383616
- ADM05008013P 0010990832 00643169383623
- ADM05008013P 0010896018 00643169383623
- ADM05020013P 0010904203 00643169975019
- ADM06004013P 0010772773 00643169383258
- ADM06004013P 0010947006 00643169383258
- ADM06006013P 0010968232 00643169383265
- ADM06006013P 0010968233 00643169383265
- ADM06008013P 0010965798 00643169383272
Distribution
Distributed nationwide across the United States.
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