Datascope Introducer Dilator in IAB Insertion Kits
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
Sensation Plus Packaged Insertion Kit |
3000296174 |
0884-00-0019-22 |
Sensation Intra-Aortic Balloon Catheter Datascope Extend. W/Ins Kit |
More than 10 numbers, contact manufacturer. |
0684-00-0469-01 |
Linear Intra-Aortic Balloon Catheter With Insertion Kit |
More than 10 numbers, contact manufacturer. |
0684-00-0480-02 |
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 |
Sensation Plus |
More than 10 numbers, contact manufacturer. |
0684-00-0568-01 |
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
Datascope Corp.
15 Law Drive, Fairfield, New Jersey, United States, 07004
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