DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Reported: September 29, 2021 Initiated: August 24, 2021 #Z-2504-2021
Product Description
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Reason for Recall
Potential for a wire protrusion through the left heart vent catheter tip
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 51,494 units
- Distribution
- Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only. Recalled by Medtronic Perfusion Systems. Units affected: 51,494 units.
Why was this product recalled? ▼
Potential for a wire protrusion through the left heart vent catheter tip
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2504-2021.
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