Datascope Introducer Dilator in IAB Insertion Kits
Brand(s)
Last updated
Summary
Product
Datascope Introducer Dilator in IAB Insertion Kits
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Reinforced Introducer Set | More than 10 numbers, contact manufacturer. | 0684-00-0403-05 0684-00-0403-10 0684-00-0403-06 |
| Sensation Plus Packaged Insertion Kit | 3000296174 3000308639 3000303090 3000260272 | 0884-00-0019-22 0884-00-0019-23 |
| Sensation Intra-Aortic Balloon Catheter Datascope Extend. W/Ins Kit | More than 10 numbers, contact manufacturer. | 0684-00-0469-01 0684-00-0470-01 |
| Linear Intra-Aortic Balloon Catheter With Insertion Kit | More than 10 numbers, contact manufacturer. | 0684-00-0480-02 0684-00-0479-01 0684-00-0479-02 0684-00-0478-02 0684-00-0480-01 0684-00-0478-01 |
| Insertion Kit For Use With Linear | More than 10 numbers, contact manufacturer. | 0884-00-0019-13 |
| Insertion Kit For Use With Sensation Iabs | More than 10 numbers, contact manufacturer. | 0884-00-0019-16 |
| 8fr Intra-Aortic Balloon Catheters | More than 10 numbers, contact manufacturer. | 0684-00-0296-02 0684-00-0296-01 |
| Sensation Plus | More than 10 numbers, contact manufacturer. | 0684-00-0568-01 0684-00-0576-01 |
Issue
There have been customer reports of the introducer dilator included within Datascope/Getinge IAB insertion kits fracturing at the hub when attempting to remove the introducer dilator from the sheath, leaving the introducer dilator body housed within the sheath.
Recall start date: July 4, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Datascope Corp.
15 Law Drive, Fairfield, New Jersey, United States, 07004
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-73938
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