Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 18, 2015
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 AMP040120152 AMP335210152 AMP020120152 AMP025080152 AMP030040152 AMP035120152 AMP040150152 AMP354210152; OUS: AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD03004
Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Vascular, Inc. recalled Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 … - a moderate-severity action.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 … was recalled by Medtronic Vascular, Inc. in November 18, 2015. Reason: Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potentia…. Check the official notice for the remedy. Verify recall #Z-0243-2016 with the FDA Devices before acting.
The recall
Medtronic Vascular, Inc. issued this moderate-severity FDA Devices recall-Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potentia….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- November 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0243-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0243-2016) was formally reported on November 18, 2015, with the manufacturer initiating the action on October 23, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Vascular, Inc. is listed as the recalling firm, operating out of Santa Rosa, CA. Federal records list the affected scope as 1652 units in US; 4243 units OUS..
The documented reason for this recall is: Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product. Distribution data in the federal record shows the product reached: Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia Austria Belgium Brazil China Colombia Costa Rica Czech Republic Denmark Dominican Republic Egypt France Georgia Germany Hong Ko…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1652 units in US; 4243 units OUS.
Related Recalls
6
3 from same agency
Product description
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 AMP040120152 AMP335210152 AMP020120152 AMP025080152 AMP030040152 AMP035120152 AMP040150152 AMP354210152; OUS: AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD030080002 AMD035150002 AMD040150152 AMD354210152 AMD030080152 AMD035150152 AMD225210002 AMD030120002 AMD040040152 AMD225210152 AMD030120152 AMD040080002 AMD253210002 AMD030150002 AMD040080152 AMD253210152 Cardiovascular: Intended for use in Angioplasty
Reason for recall
Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0243-2016 |
| Date reported | November 18, 2015 |
| Date initiated | October 23, 2015 |
| Recalling firm | Medtronic Vascular, Inc. |
| Firm location | Santa Rosa, CA |
| Affected scope | 1652 units in US; 4243 units OUS. |
| Distribution | Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia Austria Belgium Brazil China Colombia Costa Rica Czech Republic Denmark Dominican Republic Egypt France Georgia Germany Hong Kong Hungary India Ira… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0243-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 AMP040120152 AMP335210152 AMP020120152 AMP025080152 AMP030040152 AMP035120152 AMP040150152 AMP354210152; OUS: AMD025150152 AMD030150152 AMD040120002 AMD335210002 AMD030040002 AMD035040152 AMD040120152 AMD335210152 AMD030040152 AMD035120002 AMD040150002 AMD354210002 AMD030080002 AMD035150002 AMD040150152 AMD354210152 AMD030080152 AMD035150152 AMD225210002 AMD030120002 AMD040040152 AMD225210152 AMD030120152 AMD040080002 AMD253210002 AMD030150002 AMD040080152 AMD253210152 Cardiovascular: Intended for use in Angioplasty. Recalled by Medtronic Vascular, Inc.. Units affected: 1652 units in US; 4243 units OUS..
Why was this product recalled? ▼
Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter have a potential breach in the pouch seal enclosing the sterilized product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0243-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia Austria Belgium Brazil China Colombia Costa Rica Czech Republic Denmark Dominican Republic Egypt France Georgia Germany Hong Kong Hungary India Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands Norway Oman Pakistan Panama Peru Philippines Poland Portugal Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syria Taiwan Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom and Uruguay. ..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0243-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 18, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.