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Z-0089-2021 Class I Terminated

Recalled by Medtronic Vascular — Danvers, MA

FDA device recall Z-0089-2021 was initiated by Medtronic Vascular on August 25, 2020 and is designated Class I. Reason for recall: Subsequent failure of catheters in the field and failed quality testing The recall status is terminated (terminated April 4, 2024). Affected quantity: 505 units.

Recall Details

Product Type: Devices
Report Date: October 28, 2020
Initiation Date: August 25, 2020
Termination Date: April 4, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 505 units

Product Description

Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.

Reason for Recall

Subsequent failure of catheters in the field and failed quality testing

Distribution Pattern

Worldwide Distribution: USA (nationwide) states of: MA, PA, TN, IN, MI, WA, CA, CO, AZ, NC; and OUS countries of: Algeria, Armenia, Australia, Austria, Barbados, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Macedonia, Malaysia, Martinique, Moldova, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Tunisia, United Arab Emirates, and United Kingdom.

Code Information

Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134

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