TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
MICROVENTION INC. · Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Open FDA's page for this record- Cfres ID
- 205148
- Product res number
- Z-0868-2024
- Event date initiated
- 2023-12-21
- Event date posted
- 2024-01-31
- Recall status
- Open, Classified
- Res event number
- 93692
- Product code
- NOY
- Product description
- TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Code info
- Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
- Firm FEI number
- 3013556777
- Recalling firm
- MICROVENTION INC.
- Address 1
- 35 Enterprise
- City
- Aliso Viejo
- State
- CA
- Postal code
- 92656
- Additional info contact
- Terrence Callahan 949-899-7194
- Reason for recall
- Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
- Root cause description
- Device Design
- Product quantity
- 22 units
- Distribution pattern
- U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
- Action
On 12/21/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx Overnight Certified Letter to customers informing them that MicroVention is recalling one lot (#00003420470 of HYDRPEARL Microsphere Device (HP2S0600) due to the firm no following the prescribed manufacturing and quality processes and the affected product was inadvertently released for distribution. Specifically, the in-processing ageing step was mistakenly extended an additional five (5) days. Customers are instructed to: 1. Immediately stop using and quarantine the impacted HYDROPEARL device. 2. Inform all individuals with their organization of the recall and forward to any organizations that they may have received the affected products. 3. Complete the CUSTOMER ACKNOWLEDGEMENT FORM to gina.digioia@terumomedical.com 4. If their institution has any affected inventory, contact Customer Care at 800-888-3786 or email tmccustomer.admin@terumomedical.com to request a recall return and received RGA details to return the device(s). For questions or assistance, contact Director, Post-Market Surveillance at terrence.callahan@microvention.com
- K numbers
- K150870, K192684
- Harmonized identifiers (openFDA)
- Device name
- Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5550
- Device class
- 2
- K number
- K203276, DEN160040, K180102, K192684
- Registration number
- 1225687, 2134265, 9616684, 3005111382, 3013556777, 3015309643, 9615728, 3033589330, 2124215, 3012536737, 3008262715
- FEI number
- 3002808761, 3005111382, 3013556777, 3002095335, 3001451463, 3015309643, 3033589330, 2124215, 3012536737, 3008262715, 3002913962