| Date Initiated by Firm | June 23, 2023 |
|---|
| Date Posted | July 21, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2221-2023 |
|---|
| Recall Event ID |
92527 |
| 510(K)Number | K122628 |
|---|
| Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
|
| Product | SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Product Description Part Number
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE D684-00-0568-05
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) D684-00-0568-09
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY D684-00-0568-01U
PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB D884-00-0019-22 |
|---|
| Code Information |
Product Description UDI
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES 10607567108063
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) 10607567109428
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE 10607567109442
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) 10607567113166
SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY 10607567109565
PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB 10607567108612
|
Recalling Firm/
Manufacturer |
Datascope Corp.
15 Law Dr Unit 1
Fairfield NJ 07004-3206
|
| For Additional Information Contact | Datascope/Getinge Customer Service
888-943-8872 |
|---|
Manufacturer Reason
for Recall | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Firm notified customers on June 23, 2023 via letter.
Customers were made aware of the potential for the device to break during use and the risk of using the device. Customers were given alternate solutions to continue using the IAB Catheter with alternative sheath/dilator combinations. Customers may also return their affected product for a credit.
The firm will continue to ship product to customers who choose to continue receiving it. However, product currently being shipped is potentially affected by the same issue.
Datascope/Getinge has identified the issue with the introducer dilator and is working with the supplier towards a resolution.
If you have any questions, please contact your Datascope/Getinge representative or call Datascope/Getinge Customer Service at 1-888-943-8872, options 2, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
|
|---|
| Quantity in Commerce | 321,609 total kits |
|---|
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = DSP
|
|---|
