CLASS I Device recall · Reported 28 Oct 2020 · FDA Enforcement Report

Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon recalled

Medtronic Vascular is recalling Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, Pediatric, Single, distributed nationwide in the US. The recall was initiated on 25 Aug 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Numbers : GFCP2154 GFCR2591 GFCR2592 GFCS2156 GFCU2199 GFCV2587 GFCW1652 GFCW2431 GFCX2712 GFCY2997 GFDN0246 GFDN3553 GFDN3554 GFDN3555 GFDP2922 GFDQ2500 GFDR2919 GFDS2209 GFDS2210 GFDT2188 GFDT2189 GFDT2204 GFDT2205 GFDU2170 GFDU2171 GFDV2179 GFDV2180 GFDV2181 GFDW2390 GFDW2391 GFDW2392 GFDX2711 GFDX2712 GFDY1135 GFDY1136 GFDZ1692 GFDZ1693 GFEP1181 GFEP1182 GFEP1183 GFEP1184 GFER2080 GFER2081

Quantity recalled2356 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0087-2021
FDA event ID: 86381
Recalling firm: Medtronic Vascular, Danvers, MA
Classification: Class I
Status: Terminated
Recall initiated: 25 Aug 2020
FDA classified: 16 Oct 2020
Reported: 28 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

25 Aug 2020	Recall initiated by company
16 Oct 2020	Classified by FDA	+52 days
28 Oct 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subsequent failure of catheters in the field and failed quality testing

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 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.

Where it was distributed

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.

Nationwide Arizona California Colorado Indiana Massachusetts Michigan North Carolina Pennsylvania Puerto Rico Tennessee Washington

Questions about this recall

Why was it recalled?

Subsequent failure of catheters in the field and failed quality testing

Which lots are affected?

Lot Numbers : GFCP2154 GFCR2591 GFCR2592 GFCS2156 GFCU2199 GFCV2587 GFCW1652 GFCW2431 GFCX2712 GFCY2997 GFDN0246 GFDN3553 GFDN3554 GFDN3555 GFDP2922 GFDQ2500 GFDR2919 GFDS2209 GFDS2210 GFDT2188 GFDT2189 GFDT2204 GFDT2205 GFDU2170 GFDU2171 GFDV2179 GFDV2180 GFDV2181 GFDW2390 GFDW2391 GFDW2392 GFDX2711 GFDX2712 GFDY1135 GFDY1136 GFDZ1692 GFDZ1693 GFEP1181 GFEP1182 GFEP1183 GFEP1184 GFER2080 GFER2081

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 86381

Reported	Class	Recall	Company	Reason	Where
28 Oct 2020	CLASS I	Rashkind Balloon Septostomy Catheter, 4F, Closed end recalled	Medtronic Vascular	Device Malfunction	Nationwide
28 Oct 2020	CLASS I	Rashkind Balloon Septostomy Catheter, 5F, Closed end recalled	Medtronic Vascular	Device Malfunction	Nationwide

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