Medtronic Recalls Amphirion Deep PTA Balloon Catheters Due to Seal Breach
Medtronic is recalling Amphirion Deep PTA Balloon Catheters because a potential breach in the pouch seal may compromise the sterilized product.
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: The recall is classified as FDA Class II. The hazard involves a potential breach in the sterilization seal, which poses a risk of infection or other harm if the product is used, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Vascular, Inc. is recalling select lots of the Amphirion Deep OTW PTA Balloon Catheter. The recall was initiated because the company discovered a potential breach in the pouch seal that encloses the sterilized product. This defect could affect the sterility of the catheters.
The affected products are intended for use in angioplasty. The recall covers 1,652 units distributed in the United States and 4,243 units distributed outside the United States. The distribution pattern includes the United States (nationwide, including Puerto Rico) and numerous countries worldwide, including Australia, Austria, Belgium, Brazil, China, and others.
Healthcare providers and consumers should stop using the affected lots immediately. Medtronic is the recalling firm responsible for managing the recall. Specific model numbers and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiovascular
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 numbers: AMD015020002: 209633629
- 209882401
- 209981044
- AMD015020151
- 209436628
- AMD015020152
- 209821677
- 209900858
- 210046728 AMD020040002
- 209425805
- 209601495
- 209760077
- 209821680
- AMD020040152
- 209406894
- 209425802
- 209471311
- 209532785
- 209551995
- 209601496
Distribution
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