Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 O

FDA device recall Z-1988-2025 · posted 2025-06-18 · Open, Classified

Recall details

Recalling firm

BALT USA, LLC

Reason for recall

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

Action taken

On 05/08/2025, the firm sent via priority mail and an, "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that defect impacting specific lots of the Optima and Prestige Coil Systems, in which the distal 3 cm radiopaque (RO) marker may not be visible under fluoroscopy. Customers are instructed to: As a voluntary alternative to returning the affected products, devices from the affected lots can be inspected by trained hospital personnel for the presence of the RO marker using available fluoroscopy imaging equipment prior to a clinical procedure. It is important to conduct this inspection as soon as possible. The image is achieved by taking the fluoroscopic image of the coil system within the unopened box. 1) If the image contains the RO marker, as exemplified from Figure 1, i. Complete the Notice of Receipt (refer to the annex on page 5) indicating the verified results. ii. Mark the inspected boxes with the date and time of the fluoroscopy test and the name of the person performing the test. iii. Return the product back to your inventory with no further action required. iv. Send the completed Notice of Receipt to Balt USA at QA@baltgroup.com. 2) If the image does not contain the RO marker from Figure 2 or if the RO marker is not visually discernable, contact Balt USA at QA@baltgroup.com to process the return of the product. If customers desire to return the products: Distribution agents or Hospital Staff: -Identify and locate the affected Coil System and cease all use of the affected product(s). -For returning collect and put in quarantine and then return them to Balt USA through the usual RMA procedure by contacting our Customer Service. -Contact Balt USA at QA@baltgroup.com or phone +949-788-1443.

Root cause

Vendor change control

Status

Open, Classified

Product code

HCG

Quantity affected

2889 devices

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN,

Date initiated

2025-05-08

Date posted

2025-06-18

Location

Irvine, CA

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