CLEARVIEW® 31225Recalls & reported problems
Medtronic, Inc. · SHUNT 31225 ARTERIOTOMY 2.25MM 5PK 15LA · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20885074257444), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
1 other recall cover devices cleared under the same FDA submission (K120612); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED THAT THE PACKAGING OF THE ARTERIOTOMY SHUNT WAS IMPROPERLY SEALED OVER THE DEVICE PRIOR TO USE, RESULTING IN A LOSS OF PRODUCT STERILITY. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MATERIAL WAS PROTRUDING FROM THE STERILE AREA OF THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288703 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K120612. One submission often covers many models, so check the product and lot details in each record.
- Z-1803-2024 · Mar 19, 2024 · Open, ClassifiedMedtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView 2
Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices
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- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.