FDA Medical Device Recalls (openFDA)
Millar Instruments, Inc: Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.
- Recall number
- Z-1725-2011
- Recalling firm
- Millar Instruments, Inc
- Product
- Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.
- Status
- Terminated
- Initiated
- 2011-03-08
- Posted
- 2011-03-24
- Terminated
- 2011-06-27
- Reason
- Possibility of epoxy debris particles inside the catheter lumen.
- Root cause
- Process design
- Action
- The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed. If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.
- Quantity
- 1080 units
- Distribution
- MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.
- Lot, serial or model codes
- 800-4219-1 and 800-4219-3 Listing #: D055900 and D055901
- 510(k) numbers
- ["K952773","K993694"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1625382
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28