CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Reinforced Introducer Sets Maquet recalled by Datascope

Datascope is recalling Reinforced Introducer Sets Maquet, distributed in 32 states. The recall was initiated on 20 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT

Quantity recalled102

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-0932-2020
FDA event ID: 84521
Recalling firm: Datascope, Fairfield, NJ
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2019
FDA classified: 1 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

20 Nov 2019	Recall initiated by company
1 Feb 2020	Classified by FDA	+73 days
12 Feb 2020	Published in enforcement report	+11 days

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

Reason for recall

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

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

Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.

Where it was distributed

US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

Alaska Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi North Carolina North Dakota

Questions about this recall

Is Reinforced Introducer Sets Maquet recalled?

Yes. Datascope recalled Reinforced Introducer Sets Maquet on 20 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0932-2020.

Why was it recalled?

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Which lots are affected?

Part Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT

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 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 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.

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