CLASS II Device recall · Reported 2 Dec 2020 · FDA Enforcement Report

Cardioblate CryoFlex, Surgical Ablation Probe recalled

Medtronic ATS Medical is recalling Cardioblate CryoFlex, Surgical Ablation Probe, distributed nationwide in the US. The recall was initiated on 12 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000

Quantity recalled15 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-0495-2021
FDA event ID: 86666
Recalling firm: Medtronic ATS Medical, Plymouth, MN
Classification: Class II
Status: Terminated
Recall initiated: 12 Oct 2020
FDA classified: 25 Nov 2020
Reported: 2 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

12 Oct 2020	Recall initiated by company
25 Nov 2020	Classified by FDA	+44 days
2 Dec 2020	Published in enforcement report	+7 days

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

Reason for recall

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

Nationwide

Questions about this recall

Why was it recalled?

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Which lots are affected?

Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000

Where was it sold?

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

3 other products · FDA event 86666

Reported	Class	Recall	Company	Reason	Where
2 Dec 2020	CLASS II	Cardioblate CryoFlex, Surgical Ablation Probe recalled	Medtronic ATS Medical	Sterility	Nationwide
2 Dec 2020	CLASS II	Cardioblate CryoFlex, Surgical Ablation Probe recalled	Medtronic ATS Medical	Sterility	Nationwide
2 Dec 2020	CLASS II	Cardioblate CryoFlex, Surgical Ablation Probe recalled	Medtronic ATS Medical	Sterility	Nationwide

More recalls from Medtronic ATS Medical

All 5

Reported	Class	Recall	Company	Reason	Where
2 Dec 2020Device	CLASS II	Cardioblate CryoFlex, Surgical Ablation Probe recalled	Medtronic ATS Medical	Sterility	Nationwide
2 Dec 2020Device	CLASS II	Cardioblate CryoFlex, Surgical Ablation Probe recalled	Medtronic ATS Medical	Sterility	Nationwide
2 Dec 2020Device	CLASS II	Cardioblate CryoFlex, Surgical Ablation Probe recalled	Medtronic ATS Medical	Sterility	Nationwide
1 Apr 2020Device	CLASS II	Medtronic Open Pivot Aortic Valve Graft recalled	Medtronic ATS Medical	Other	MN

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide