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

Rashkind Balloon Septostomy Catheter, 5F, Closed end recalled

Medtronic Vascular is recalling Rashkind Balloon Septostomy Catheter, 5F, Closed end, Pediatric, Single Lumen Product, 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 : GFCT1699 GFCT2030 GFCW2430 GFCX2784 GFCY2476 GFCY3001 GFDN0247 GFDN3546 GFDR2901 GFDT2170 GFDT2200 GFDU2168 GFDV2177 GFDW2388 GFDW2389 GFDW2399 GFDX2709 GFDY1132 GFDZ1690 GFDZ1691 GFEN2173

Quantity recalled711 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-0088-2021
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, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 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

Is Rashkind Balloon Septostomy Catheter, 5F, Closed end, Pediatric, Single Lumen Product recalled?

Yes. Medtronic Vascular recalled Rashkind Balloon Septostomy Catheter, 5F, Closed end, Pediatric, Single Lumen Product on 25 Aug 2020. The recall is Class I and its status is Terminated. Recall number Z-0088-2021.

Why was it recalled?

Subsequent failure of catheters in the field and failed quality testing

Which lots are affected?

Lot Numbers : GFCT1699 GFCT2030 GFCW2430 GFCX2784 GFCY2476 GFCY3001 GFDN0247 GFDN3546 GFDR2901 GFDT2170 GFDT2200 GFDU2168 GFDV2177 GFDW2388 GFDW2389 GFDW2399 GFDX2709 GFDY1132 GFDZ1690 GFDZ1691 GFEN2173

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

More recalls from Medtronic Vascular

All 227

Reported	Class	Recall	Company	Reason	Where
18 May 2022Device	CLASS II	Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled	Medtronic Vascular	Sterility	Nationwide
18 May 2022Device	CLASS II	Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter recalled	Medtronic Vascular	Sterility	Nationwide
1 Dec 2021Device	CLASS II	Endurant IIs Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant II Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide