The Recall Desk
Agency classClass IIOur severity:CriticalFDA (Devices)·Z-2217-2023·Announced 2023-08-02

Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk

The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class II recall with a reported patient death and 3 serious adverse events. Per the severity rubric, the presence of reported fatalities results in a score of 5 regardless of other factors.

Plain-English summary

Datascope Corp. is recalling SENSATION 7 Fr. Intra-Aortic Balloon (IAB) Catheters and Accessories used for cardiac counterpulsation therapy. The recall encompasses multiple variants manufactured across multiple countries, totaling 321,609 units distributed domestically and worldwide.

During insertion, the introducer dilator may fracture at the hub, potentially leaving fragments inside the catheter sheath. This can damage the femoral artery or descending aorta, cause blood clots (embolization), or require emergency surgical repair and delay necessary cardiac therapy.

Datascope has documented 10 complaints, including 3 serious adverse events and 1 patient death. Healthcare facilities should immediately cease using affected devices and contact the manufacturer for guidance. Patients who have already received these catheters should discuss their individual situation with their cardiologist or healthcare provider.

The recalled product

Product
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES…
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard
Affected units
321,609

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • US ONLY 10607567109558 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Datascope Corp.

See all →

Same hazard · introducer fracture

See all →

Similar recalls