Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.: 804113) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.: 804113)
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Lot Numbers: GC06, GC27, GD27, GG19, GK07, GL05, GM02, GM30, HA02, HC05, HD12, HE23, HF29, HH23, HK27, HM22, HP03 and KA14.
Products Sold
Lot Numbers: GC06, GC27, GD27, GG19, GK07, GL05, GM02, GM30, HA02, HC05, HD12, HE23, HF29, HH23, HK27, HM22, HP03 and KA14.
Terumo Cardiovascular Systems Corp is recalling Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump due to Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.
Recommended Action
Per FDA guidance
Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.
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