Device recall: Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152…
Class II FDA enforcement event 72502. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Medtronic Vascular, Inc. started this device recall on 23 Oct 2015. The firm address in the FDA record is in Santa Rosa, CA. FDA put the recall in Class II. FDA event 72502 has 1 product record. The first FDA enforcement report date is 18 Nov 2015. The record gives the status Terminated, with the termination date 31 Jul 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Medtronic Vascular, Inc., Santa Rosa, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0243-2016 | 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… | 1652 units in US; 4243 units OUS. | Class II | Terminated | 18 Nov 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 13
Other events of the firm
Official channels
- FDA enforcement report Z-0243-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72502. https://recallregister.com/fda/ii/72502/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 72502?
- The FDA record gives this quantity:
1652 units in US; 4243 units OUS.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.