FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
- Recall number
- Z-2613-2011
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
- Status
- Terminated
- Initiated
- 2011-05-03
- Posted
- 2011-06-22
- Terminated
- 2012-07-18
- Reason
- The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a change in the pressure dome's manufacturing process.
- Root cause
- Other
- Action
- Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 3, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were sent 10 replacement pressure monitoring kits with the removal notice as immediate replacements. The firm will send additional replacements to customers that have more than 10 units of affected product as noted on the Customers' returned reponse form. Customers that received the custom packs were provided stickers to identify the recalled packs. The customers were instructed not to open the packs to remove the affected pressure monitoring kit prior to clinical use, but to replace the pressure domes at the time of use. For more information please contact Terumo Cardiovascular Customer Service at 800- 521-2818.
- Quantity
- 19495 units
- Distribution
- Worldwide Distribution -- USA (nationwide )including the states AR, CA, FL, GA, MO, MT, NC, ND, OK, OR, PA, TN, TX, UT, VA, WA and WY, and the countries of Argentina, Belgium, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatamala, Honduras, Hong Kong, Indonesia, Kuwait, Malaysia, Mexico, Pakistan, Panama, Philippines, Singapore, South Korea, Thailand, United Arab Emirates, Uruguay and Vietnam
- Lot, serial or model codes
- 0511829, 0519808, 0522673, 0537066, 0538520, 0544571, 0548624, 0552118, 0555878, 0557544, 0563808, 0565139, 0571582, 0575070, 0578021, 0578529, 0579318, 0580173, 0582267, 0584399, 0587165, 0589587, 0592742, 0593799, 0595311, 0595312, 0604098.
- 510(k) numbers
- ["K022947","K871131","K915183"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- 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