Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 27, 2017
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Stylette removal difficulties on the Euphora and Solarice products.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Vascular Galway DBA Medtronic Ireland recalled Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary … - a moderate-severity action.
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary … was recalled by Medtronic Vascular Galway DBA Medtronic Ireland in September 27, 2017. Reason: Stylette removal difficulties on the Euphora and Solarice products.. Check the official notice for the remedy. Verify recall #Z-3136-2017 with the FDA Devices before acting.
The recall
Medtronic Vascular Galway DBA Medtronic Ireland issued this moderate-severity FDA Devices recall-Stylette removal difficulties on the Euphora and Solarice products..
- Moderate
- severity level
- Class II
- classification
- September 27, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3136-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3136-2017) was formally reported on September 27, 2017, with the manufacturer initiating the action on July 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Vascular Galway DBA Medtronic Ireland is listed as the recalling firm, operating out of Galway, N/A. Federal records list the affected scope as 69,081 (US).
The documented reason for this recall is: Stylette removal difficulties on the Euphora and Solarice products. Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RI…. 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 - 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 - 40,422 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
69,081 (US)
Related Recalls
6
0 from same agency
Product description
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Reason for recall
Stylette removal difficulties on the Euphora and Solarice products.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3136-2017 |
| Date reported | September 27, 2017 |
| Date initiated | July 13, 2017 |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Firm location | Galway, N/A |
| Affected scope | 69,081 (US) |
| Distribution | Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH R… |
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-3136-2017) 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? ▼
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.. Recalled by Medtronic Vascular Galway DBA Medtronic Ireland. Units affected: 69,081 (US).
Why was this product recalled? ▼
Stylette removal difficulties on the Euphora and Solarice products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2017. Severity: Moderate. Recall number: Z-3136-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KOREA, LATVIA, LEBANON, LIECHTENSTEIN, LITHUANIA, MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PAPUA NEW GUINEA, PHILIPPINES, POLAND, PORTUGAL, REUNION, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VIET NAM.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3136-2017) 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 September 27, 2017. 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.