Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
UDI: 00886799000038
Products Sold
UDI: 00886799000038; Serial Numbers: 20288 20289 20290 20291 20292 20293 20294 20295 20296 20299 20300 20301 20302 20306 20307 20308 20309 20310 20312 20317 20318 20320 20321 20322 20323 20324 20326 20328 20329 20331 20332 20334 20338 20339 20341 20342 20343 20344 20345 20346 20347 20348 20349 20350 20351 20352 20358 20365 20368 20373 20374 20375 20381 20382 20383 20384 20385 20387 20388 20392 20393 20395 20396 20397 20398 20399 20401 20402 20403 20404 20405 20408 20410 20411 20412 20555 20556 20557 20558 20559 20560 20561 20562 20563 20564 20565 20566 20567 20568 20569 20570 20571 20572 20573 20574 20575 20576 20577 20578 20579
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usa due to Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Recommended Action
Per FDA guidance
Urgent Medical Device Removal notification letters dated 8/25/20 were sent to customers. Terumo CVS is removing the affected ABD sensors from the field. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement device and subsequent return of the affected unit. The replacement ABD sensor supplied by Terumo CVS will be part of a kit containing a cable and a bracket which are not affected by this removal. The cable and the bracket do not require replacement. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Review Product Return instructions when provided by separate email communication. Tracking information on replacement device will be provided as well as a Return Goods Authorization (RGA) number to facilitate the return of the affected device., 4. Once the replacement shipment has been received, remove the affected ABD sensor and replace it with the new ABD sensor provided by Terumo CVS. 5. Return affected ABD sensor using the packing container and shipping materials received with the replacement ABD device. Please mark the RGA number on the outside of the box. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Recall Fax: 1.734.741.6149 Review this Medical Device Correction and assure that all users have received notice of this issue. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement ABD sensor and subsequent return of the affected unit. Terumo CVS recommends that you continue using your ABD sensor while waiting for a replacement. If you experience an ABD sensor failure, or have questions, contact Terumo CVS Customer Service: 800.521
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026