This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
- Product Names:
- Tack Endovascular System (4F,1.5-4.5mm), 150cm
- Tack Endovascular System (6F, 3.5 - 6.0mm), 135c
- Tack Endovascular System (6F, 4.0 - 8.0mm), 135cm
- Unique Device Identifier (UDI)/Catalog Number:
- 00863328000196/154150041
- 00863328000127/156135061
- 00850003494036/206135061
- Batch Codes:
- 332905 – 349049
- 332824 – 336121
- 331281 – 336152
What to Do
- Stop use of the Tack Endovascular System.
On January 10, 2025, Philips Image Guided Therapy Services sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Immediately check product inventory for affected product.
- Quarantine affected devices to prevent use.
- Do not open or use any identified products.
- Complete, return, and sign the response form attached to the letter within seven days.
- Philips will start the return and credit process based on the completed form.
- Return the response form within seven days even if no product is present.
- Acknowledge receipt of the notification by completing the response form to [email protected].
- Share the notice with all device users and to any place where affected product may have been transferred.
Reason for Recall
Philips is recalling Tack Endovascular Systems due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant. All customers should stop using the Tack Endovascular System immediately. Philips will no longer distribute this system for use.
The use of affected product may cause serious adverse health consequences, including short-term risks of partial or completely blocked blood flow (occlusion), holes or tears in the inner lining of the artery (dissection) through the entire artery wall (perforation), as well as long term risks such as pain, tissue loss, re-narrowing of a widened or stented vessel (restenosis), the need for bypass surgery, amputation, and death. There have been 20 reported injuries. There have been no reports of death.
Device Use
The Tack Endovascular System is used to treat dissection of the blood vessels after they are widened using a balloon or stent (angioplasty). The Tack implant attaches damaged tissue to the inner lining of the blood vessel to repair dissection.
